Clinical TrialKetaminePlaceboCompleted

Ketamine Modulation of Reward Processing fMRI in Remitted Unmedicated MDD: Double-Blind Crossover (Kotoula 2022)

Double-blind within-subject crossover neuroimaging study (Biol Psychiatry Cogn Neurosci Neuroimaging 2022 Mar; Kotoula V, Stringaris A, Mackes N, Mazibuko N et al.; PMID 34126264; DOI 10.1016/j.bpsc.2021.05.009). Participants: n=18 adults (21–65 yr) in remission from DSM-IV MDD; antidepressant-free; no current symptoms; Inventory of Depressive Symptomatology score <32 and documented prior nonresponse. Crossover: single IV ketamine (0.5 mg/kg over 40 min) and saline placebo on separate sessions ≥7 days apart; fMRI (3T, MID task, 96 trials) acquired 2 h post-infusion. Blood samples at pre-infusion, immediately post-infusion and 2 h post-infusion for ketamine, norketamine, and HNK metabolites. Primary ROIs: bilateral ventral striatum, dorsal striatum, VTA, amygdala, insula, sgACC. CT.gov: 0 hits; PubMed DataBankList: empty; no registration number in methods.

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Target Enrollment
18 participants
Study Type
interventional
Design
Non-randomized

Study Arms & Interventions

Ketamine 0.5mg/kg

experimental

Single 40-minute steady state intravenous infusion of ketamine (0.5 mg/kg)

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    40min steady state infusion

Placebo

placebo

Single 40-minute steady state intravenous infusion of 0.9% saline solution

Interventions

  • Placebo null
    via IV• single dose• 1 doses total

    0.9% saline solution administered via 40min steady state infusion

Study Protocol, Arms & Participants

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Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment18 participants
  • Timeline
    Start: 2018-01-01
    End: 2021-01-01
  • Compounds
    KetaminePlacebo

Related Publications

Open AccessindividualPrimary

Ketamine Modulates the Neural Correlates of Reward Processing in Unmedicated Patients in Remission from Depression

This double-blind, placebo-controlled study (n=37) found that ketamine improved responses to rewards two hours after depressed patients had received ketamine (35mg/70kg) treatment. This correlated with neurological observations (increases in activation of NAc, the putamen, the insula, and the caudate).

Published
Journal
Biological Psychiatry
Authors
Kotoula, V., Stringaris, A., Mackes, N., Mazibuko, N., Hawkins, P. C. T., Furey, M., Curran, V., Mehta, M. A.

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